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    • Home
    • Services
      • Research, Mfg, Supply ch.
      • Quality & Regulatory
      • Business Dev & Project M.
    • Careers
    • Contact
iXpert Advisors
  • Home
  • Services
    • Research, Mfg, Supply ch.
    • Quality & Regulatory
    • Business Dev & Project M.
  • Careers
  • Contact

Quality Compliance & Regulatory Consulting

Quality and regulatory consulting
Biotech & Pharmaceutical Compliance Consulting

Quality Compliance and Regulatory

At iXpert we offer complete Quality and Regulatory support. Our highly Qualified experts provide pharmaceutical Complience consulting advice from the early phases of pharmaceutical development through marketing applications and post-marketing activities.

Quality

Quality Assurance

GMP Manufacturing Oversight

Quality Management

Deviation and CAPA

Verification and Validation

SOP Development and SOP Audits

Vendor Audits

Inspection Readiness

Quality Control

Quality Audits

Document control support

Regulatory

CMC Regulatory

Clinical Regulatory

Authoring support

Medical Writing

INDs/IMPD/NDA/ANDA/MAA/BLA filings

US, Canada, EU and International Submissions

White paper

Regulatory Strategy

eCTD Submissions

Response to Regulatory Queries

Assist with due diligence activities for investors/licensees

Work with sponsors and regulatory authorities through the resolution of complex development issues

More...

Research, Manufacturing & Supply ChainBusiness Development & Project Management

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